Drug Master Files for: ATOMOXETINE HYDROCHLORIDE

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ATOMOXETINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18440	A	II	6/22/2005	DR REDDYS LABORATORIES LTD	ATOMOXETINE HYDROCHLORIDE USP
19605	A	II	3/16/2007	AUROBINDO PHARMA LTD	ATOMOXETINE HYDROCHLORIDE USP
19623	I	II	7/10/2006	OLON SPA	ATOMOXETINE HYDROCHLORIDE DRUG SUBSTANCE
19861	A	II	10/12/2006	MYLAN LABORATORIES LTD	ATOMOXETINE HYDROCHLORIDE USP
20070	A	II	5/18/2007	APOTEX PHARMACHEM INC	ATOMOXETINE HYDROCHLORIDE
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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